Senior Scientist_Drug Product Development

2 months ago

Kozhikode, India Enzene Biosciences Ltd Full time

Job description

Role & responsibilities

  • Planning and execution of Novel and NIF formulation development for liquid/lyophilized protein formulation including Lyophilization cycle development.
  • Planning, execution and evaluation of uf/df process for high concentration monoclonal antibody formulation
  • Planning Product and process development studies (product contact part compatibility, hold time, freeze thaw, thermal cycling study, agitation study, Photostability study, temperature excursion study, In-use study, reconstitution solution
  • ability study, preservative efficacy)
  • Planning and execution of Product and process characterization studies, including DoE based ranging study, data evaluation, statistical analysis
  • Development of scale down model for drug product manufacturing process
  • Preparation of technology transfer document and successful tech transfer to manufacturing unit,
  • Evaluation of vendor and planning of outsource studies like Filter validation, extractable leachable study, Preservative efficacy testing, nitrosamine testing, review of protocols, reports.
  • Experience on subvisible particles testing using different techniques (MFI, HIAC),
  • Functionality method testing - Method development and qualification for Universal testing machine (Break loose glide force, RNS removal force, Safety device activation force, override force etc..)
  • Preparation of pharmaceutical development report as per ICH Q8/CTD
  • Guiding team for product developmental activities.
  • Technical evaluation of Vendor for pen device, auto injectors, prefilled syringe
  • Design verification testing planning and functionality testing of Device as per ISO11608 and ISO11040 for pen injector, auto injector and prefilled syringes
  • Risk assessment of product contact part, CCS, elemental impurities, nitrosamine impurities in finished product, process evaluation report,
  • Preparation of technical documentation design control documents including design history file as per 21 CFR par 820 Preparation of technical file/documentation for NB submission for prefilled syringe and pen (drug device combination product)
  • Review of protocols, reports, risk assessment documents, TTD, Change control, MFR, BMR
  • Regulatory documents preparation support
  • Strong data interpretation and troubleshooting skills
  • Sound cross functional communication skills, interpersonal skills
  • Accountable for Cross-functional communication with internal and external vendors/clients for technical queries in consultation with reporting manager
  • The candidate shall be Accountable for Maintain environment, health, and safety (EHS) requirements at workplace to ensure individual and lab/plant safety


Technical Skill Requirement:

  • Knowledge and hands on experience on of MFI method development and qualification
  • Knowledge and hands on experience on Functionality test method development and qualification using UTM for
  • design verification testing
  • Knowledge and hands on experience on Lyophilization cycle development and characterization
  • Knowledge and hands on experience on viscometer, density meter, liquid particle counter, benchtop filling
  • machine
  • Technical abilities to troubleshoots the problems/failures
  • Knowledge and hands on experience on JMP software and statistical analysis, Hands on experience on data
  • analytics using different statistical tools will be added advantage
  • Strong commitment and dedication towards work, enthusiasm, motivation, and persuasive ability in a team and
  • experience of leading team of 1-2 members will be added advantage.
  • Candidate should able to Work independently, analyse and interpret experimental data, and present/document
  • experimental results at meetings.


Experience & Qualification-

11+ year in drug product development, formulation development, device development, technology transfer

Qualification:

M. Pharm in Pharmacutical technology or Biopharmaceutical technology

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